HANDSOAP- benzalkonium chloride liquid 
Campari Science & Technology (Suzhou) Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient(s)

BENZALKONIUM CHLORIDE 0.45%、CHLORHEXIDINE DIGLUCONATE 0.20%

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

WATER、COCAMIDOPROPYL BETAINE、DECYL GLUCOSIDE、GLYCERIN、COCAMIDOPROPYLAMINE OXIDE、SODIUM CITRATE、ARTEMISIA ARGYI LEAF EXTRACT、SODIUM HYDROXIDE、PARFUM

Package Label - Principal Display Panel

label

HANDSOAP 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54837-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE2.25 mg  in 500 mL
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE1 mg  in 500 mL
Inactive Ingredients
Ingredient NameStrength
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLYCERIN (UNII: PDC6A3C0OX)  
ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54837-002-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/15/2020
Labeler - Campari Science & Technology (Suzhou) Co., Ltd. (548374083)
Establishment
NameAddressID/FEIBusiness Operations
Campari Science & Technology (Suzhou) Co., Ltd.548374083manufacture(54837-002)

Revised: 4/2020
Document Id: a45b4cc3-2f5b-328e-e053-2a95a90aa612
Set id: a45b351d-05cc-30f9-e053-2a95a90ac9ba
Version: 1
Effective Time: 20200415
 
Campari Science & Technology (Suzhou) Co., Ltd.